Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Summary
The FDA issued a Class I for Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percut by Abbott. Reason: There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was us.
Details
Source
Device Recall
External ID
Z-2110-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Lot/Code Info: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Quantity Affected: 675 units
Reason for Recall
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Distribution
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-12
Company
Plymouth, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott has 21 FDA actions in our database, including 15 recalls and 6 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott have FDA actions?
Abbott has 21 FDA actions in our database, including 15 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2110-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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